Michael Harty (Clare, Independent) | Oireachtas source

On the mandatory open disclosure of specified serious patient incidents, we should add other patient safety incidents by regulation. It is important that we separate serious and less serious, or minor, incidents. Notification can be made to HIQA, the chief inspector of social services and the Mental Health Commission. In that regard, there should be a common database among the three of them in order that each can see what the others have been notified of. It is important that specific regulations and sections on clinical audit have been included. We will discuss many such issues in detail on Committee Stage early next year.

It is essential that open disclosure be mandatory, as was identified in A Programme for a Partnership Government. The Civil Liability (Amendment) Act 2017 maintained voluntary disclosure and the Joint Committee on Health accepted the advice of the Chief Medical Officer at the time that it was the most appropriate course of action, even though it was in contradiction to the programme for Government. It is essential that we are moving to a mandatory process, which has come on foot of Dr. Gabriel Scally's report on CervicalCheck and the deficiencies in the CervicalCheck audit process. It will put an additional onus on health professionals and health service providers, which is only right, and I am glad that it will include private hospitals as well as public, voluntary and HSE-run hospitals. It should be extended to other healthcare facilities, which could be added by regulation. Many other healthcare facilities should be included in the Bill, given that they have great potential to harm patients if they are not properly regulated. There need to be clear guidelines on how mandatory disclosure will operate and a comprehensive training process within the HSE and for health professionals - doctors, nurses and other allied professionals - on how open disclosure is to be delivered. There needs to be appropriate governance of how all of that is managed. It is important that patients and the medical profession have confidence in the process and that they believe that mandatory open disclosure will not expose them to unnecessary risk.

On the definition of serious incidents, I acknowledge there will be many types, most of which will have caused harm but others may not. They may have been near misses, or may have had the potential to cause harm but did not do so, or may have been averted before harm could develop. It is important that the health service and health professionals learn from such incidents too, and I hope to explore that on Committee Stage.

The disclosure of a serious incident should not apportion blame or guilt. Many issues are multifactorial, and while they relate to health professionals' actions, many other factors can affect adverse incidents. They may relate to excessive workload, the hours that doctors, nurses or other health professionals work, or the supports they are offered within the health structure. Such factors also need to be recognised within the legislation.

If a health professional has acted negligently, the matter cannot be decided by open disclosure but rather by the regulatory body that regulates the profession or it will be up to the courts to decide. There are protections in respect of open disclosure whereby information delivered within the process is not admissible in legal proceedings. That is important to give health professionals the confidence to engage in open disclosure. Serious adverse incidents are often a failure of a team, management or the structure of the HSE, and are not necessarily solely attributable to the health professional involved.

Doctors and patients must have confidence in the system and each health group, following the HSE's devolution through Sláintecare, should have a dedicated open disclosure unit that would involve the appropriate people - perhaps the CEO and certainly the clinical director of the hospital group - if adverse incidents happen within the community. There should be a clear line in the Bill on responsibility and on who is to make the open disclosure, to give clarity. The issue came starkly to light in respect of CervicalCheck, where there was a failure to identify who was responsible for making the open disclosure to the women being audited. That was the failure of CervicalCheck, as Dr. Scally identified. There needs to be specific training of HSE management and clinical directors on how to deliver mandatory open disclosure. It should be integrated into undergraduate training because few health professionals will get through their career without being involved in an adverse incident in some way or another. It is important that they recognise that it has happened, their responsibility for it and their responsibility to make a mandatory disclosure about it. It should be ingrained in our educational system.

There need to be supports not only for patients and their families in respect of open disclosure but also for health professionals who may have been involved in an adverse incident. In many such incidents, it is not the case that there has been negligence but it can be a career-defining moment for many health professionals. Being involved in an adverse incident may end their career or give them serious psychological issues to deal with, for which supports are needed. I mentioned excessive working hours, poor working conditions, a lack of staff, overcrowding and excessive workload, all of which are part of our health system. We need to recognise that and take it into account in respect of adverse incidents. Management should also be involved in taking some responsibility for them, not least if there are shortcomings such as those I outlined.

The current system of litigation following adverse incidents is not appropriate. There needs to be a move towards no-fault compensation within our health system, especially when it relates to audit or vaccination, where healthy people are asked to get involved in a health service for their own good. Should there be an adverse incident in either such scenario, a no-fault compensation scheme is important to remove the adversarial blame culture that has built up within the health system. Patients want an explanation and recognition for what has happened, to ensure that it will not happen to anybody else, to get reasonable compensation if they have been damaged, which is where the no-fault compensation scheme would apply, and to avoid adversarial, lengthy, stressful proceedings, which can take years, do not do anybody any good and cost a fortune. It is important that we do not fall into an element of defensive medicine and the medical profession should not be forced into it. We have to guard against that in respect of open disclosure. There has been a definition of absolute confidence. Medicine is not an exact science and it is difficult to be absolutely confident in every decision one makes. Following agreed protocols gives the health professional some protection but he or she must nonetheless deliver a service on clinical judgment. In my experience, the act of making an apology is empowering for the professional.

It is important to the person who has been damaged, but it is empowering to the professional because it takes pressure off them. It also takes pressure off the patient who has been adversely affected. I think it is part of what we should be educating our medical and nursing students for.

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